Trial · NCT01760187
Phase I Study of the Safety, Tolerability, PK & PD of Lomitapide in Japanese and Caucasian Subjects With Elevated LDL-C
NCT01760187, Phase 1, Completed, Aegerion Pharmaceuticals, Inc.; results first posted 2018-11-20
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Phase I Study of the Safety, Tolerability, PK & PD of Lomitapide in Japanese and Caucasian Subjects With Elevated LDL-C. Trials, record NCT01760187. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01760187
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase I Study of the Safety, Tolerability, PK & PD of Lomitapide in Japanese and Caucasian Subjects With Elevated LDL-C
- NCT number
- NCT01760187
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 72 participants, actual
- Lead sponsor
- Aegerion Pharmaceuticals, Inc.
- Conditions
- Healthy Volunteer
- Interventions
- lomitapide
- First posted
- 2013-01-04
- Last updated
- 2018-11-20
- Other registries' IDs
- eudract:2012-004220-37
- Results first posted
- 2018-11-20
Source ClinicalTrials.gov
Registered outcomes27
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Cmax for Lomitapide | 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose on Day 7 | Maximum observed plasma concentration for lomitapide |
| Primary | Tmax for Lomitapide | 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose on Day 7 | Time to maximum observed concentration for lomitapide |
| Primary | AUC0-t for Lomitapide | 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose on Day 7 | Area under the plasma concentration versus time curve from hour 0 to the last measurable concentration for lomitapide |
| Primary | AUC0-∞ for Lomitapide | 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose on Day 7 | Area under the plasma concentration versus time curve from zero to infinity for lomitapide |
| Primary | t1/2 for Lomitapide | 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose on Day 7 | Apparent terminal elimination half-life for lomitapide |
| Primary | Cmax for Lomitapide | 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose on Day 27 | Maximum observed plasma concentration for lomitapide |
| Primary | Tmax for Lomitapide | 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose on Day 27 | Time to maximum observed concentration for lomitapide |
| Primary | AUC0-t for Lomitapide | 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose on Day 27 | Area under the plasma concentration versus time curve from hour 0 to the last measurable concentration for lomitapide |
| Primary | t1/2 for Lomitapide | 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose on Day 27 | Apparent terminal elimination half-life for lomitapide |
| Secondary | Cmax for M1 | 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose on Day 7 | Maximum observed plasma concentration for M1 metabolite of lomitapide |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 registered outcomesOutcomes27
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Cmax for Lomitapide | 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose on Day 7 | All subjects with evaluable concentrations | ng/mL | MEAN |
| PRIMARY | Tmax for Lomitapide | 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose on Day 7 | All subjects with evaluable concentrations | hr | MEDIAN |
| PRIMARY | AUC0-t for Lomitapide | 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose on Day 7 | All subjects with evaluable concentrations | ng*hr/mL | MEAN |
| PRIMARY | AUC0-∞ for Lomitapide | 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose on Day 7 | AUC0-∞ and t1/2 were not calculated for 3 subjects in the Japanese 10mg arm because the estimated t1/2 was being much longer than half of the total sampling time. | ng*hr/mL | MEAN |
| PRIMARY | t1/2 for Lomitapide | 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose on Day 7 | AUC0-∞ and t1/2 were not calculated for 3 subjects in the Japanese 10mg arm because the estimated t1/2 was being much longer than half of the total sampling time. | hr | MEAN |
| PRIMARY | Cmax for Lomitapide | 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose on Day 27 | All subjects with evaluable concentrations | ng/mL | MEAN |
| PRIMARY | Tmax for Lomitapide | 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose on Day 27 | All subjects with evaluable concentrations | hr | MEDIAN |
| PRIMARY | AUC0-t for Lomitapide | 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose on Day 27 | All subjects with evaluable concentrations | ng*hr/mL | MEAN |
| PRIMARY | t1/2 for Lomitapide | 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose on Day 27 | All subjects with evaluable concentrations | hr | MEAN |
| SECONDARY | Cmax for M1 | 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose on Day 7 | All subjects with evaluable concentrations | ng/mL | MEAN |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 outcomesResults by group216
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Cmax for Lomitapide | Japanese 10 mg | 0.570 | Standard Deviation 0.285 | ng/mL | |
| Cmax for Lomitapide | Caucasian 10 mg | 0.436 | Standard Deviation 0.166 | ng/mL | |
| Cmax for Lomitapide | Japanese 20 mg | 1.70 | Standard Deviation 0.49 | ng/mL | |
| Cmax for Lomitapide | Caucasian 20 mg | 1.01 | Standard Deviation 0.17 | ng/mL | |
| Cmax for Lomitapide | Japanese 40 mg | 3.93 | Standard Deviation 0.75 | ng/mL | |
| Cmax for Lomitapide | Caucasian 40 mg | 3.00 | Standard Deviation 1.52 | ng/mL | |
| Cmax for Lomitapide | Japanese 60 mg | 8.29 | Standard Deviation 3.44 | ng/mL | |
| Cmax for Lomitapide | Caucasian 60 mg | 5.75 | Standard Deviation 1.78 | ng/mL | |
| Tmax for Lomitapide | Japanese 10 mg | 4 | Full Range 2 to 6 | hr | |
| Tmax for Lomitapide | Caucasian 10 mg | 5 | Full Range 2 to 12 | hr |
1 to 10 of 216Source ClinicalTrials.gov
See all 216 results by groupParticipant flow15
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cohort 1 | 20 | |
| Overall Study | STARTED | Cohort 2 | 12 | |
| Overall Study | STARTED | Cohort 3 | 12 | |
| Overall Study | STARTED | Cohort 4 | 12 | |
| Overall Study | STARTED | Placebo | 16 | |
| Overall Study | COMPLETED | Cohort 1 | 19 | |
| Overall Study | COMPLETED | Cohort 2 | 12 | |
| Overall Study | COMPLETED | Cohort 3 | 12 | |
| Overall Study | COMPLETED | Cohort 4 | 10 | |
| Overall Study | COMPLETED | Placebo | 16 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 participant flowAdverse events360
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Abdominal Discomfort | Gastrointestinal disorders | Placebo - Japanese Patients | 0 | 8 | 0 |
| other | Abdominal Discomfort | Gastrointestinal disorders | Placebo - Caucasian Patients | 0 | 8 | 0 |
| other | Abdominal Discomfort | Gastrointestinal disorders | Cohort 1- Japanese Patients | 0 | 10 | 0 |
| other | Abdominal Discomfort | Gastrointestinal disorders | Cohort 1 - Caucasian Patients | 0 | 10 | 0 |
| other | Abdominal Discomfort | Gastrointestinal disorders | Cohort 2 - Japanese Patients | 0 | 6 | 0 |
| other | Abdominal Discomfort | Gastrointestinal disorders | Cohort 2 - Caucasian Patients | 1 | 6 | 1 |
| other | Abdominal Discomfort | Gastrointestinal disorders | Cohort 3 - Japanese Patients | 1 | 6 | 1 |
| other | Abdominal Discomfort | Gastrointestinal disorders | Cohort 3 - Caucasian Patients | 0 | 6 | 0 |
| other | Abdominal Discomfort | Gastrointestinal disorders | Cohort 4 - Japanese Patients | 2 | 6 | 2 |
| other | Abdominal Discomfort | Gastrointestinal disorders | Cohort 4 - Caucasian Patients | 0 | 6 | 0 |
1 to 10 of 360Source ClinicalTrials.gov
See all 360 adverse eventsAdverse event totals30
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo - Japanese Patients | 0 | 8 |
| Total, all-cause mortality | Placebo - Caucasian Patients | 0 | 8 |
| Total, all-cause mortality | Cohort 1- Japanese Patients | 0 | 10 |
| Total, all-cause mortality | Cohort 1 - Caucasian Patients | 0 | 10 |
| Total, all-cause mortality | Cohort 2 - Japanese Patients | 0 | 6 |
| Total, all-cause mortality | Cohort 2 - Caucasian Patients | 0 | 6 |
| Total, all-cause mortality | Cohort 3 - Japanese Patients | 0 | 6 |
| Total, all-cause mortality | Cohort 3 - Caucasian Patients | 0 | 6 |
| Total, all-cause mortality | Cohort 4 - Japanese Patients | 0 | 6 |
| Total, all-cause mortality | Cohort 4 - Caucasian Patients | 0 | 6 |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01760187
GET https://conductscience.org/api/trials/v1/NCT01760187/registered?page=2